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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 2/4/2015 Class lI: PRODUCT Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 2/4/2015 Class lI: PRODUCT BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging Recall Number Z-1011-2015 REASON Unintended detector and gantry movement due to software issues. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc.,Cleveland, OH 11/12/2014. Voluntary:...Read More

Company: INNOKAS MEDICAL OY. Date of Enforcement Report 2/4/2015 Class lI: PRODUCT VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014. Recall Number Z-1022-2015 REASON If the SpO2 or RRa value is violating the respective alarm...Read More

Company:GE Healthcare Date of Enforcement Report 2/4/2015 Class lI: PRODUCT The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. Recall Number...Read More